Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer (CARDAPAC)

October 5, 2020 updated by: Fabienne Mougin-Guillaume, University of Franche-Comté

Impact of Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer, During Treatment With Trastuzumab in Adjuvant

Purpose of the study is to examine the effects of 3 months of physical activity intervention on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Primary objective: To evaluate in patients with HER2 + breast cancer, treated only by trastuzumab, the impact of three months individualized physical activity intervention (55 minutes, 3 times per week) on left ventricular ejection fraction (LVEF).

Secondary objectives: To evaluate the impact of physical activity intervention on body composition, muscle function, metabolic, hormonal and inflammatory responses, pain, fatigue and quality of life.

This study examines patients aged 18 to 85 years, diagnosed with early breast cancer with HER2 overexpression confirmed histologically and eligible to receive treatment with trastuzumab (adjuvant).

This study includes 3 assessments phases: baseline (T0), 3 months (T3) and 6 months (T6) for both arms.

The programme is organised as follows: Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " for 3 months ; Arm B (control group) "standard oncologic care".

Between T3 and T6, volontary physical activity level will follow by actimetry.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Doubs
      • Besancon, Doubs, France, 25000
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients aged 18 to 85 years
  • First breast cancer HER2 + histologically confirmed,
  • WHO grade Performance Index ≤1
  • Normal renal function (creatinine clearance ≥ 60 ml min-1)
  • Normal heart function with LVEF ≥ 50%
  • Normal liver function (AST and ALT normal)
  • Physical activity certificate issued by a cardiologist or an oncologist,
  • Active contraception or postmenopausal

Exclusion Criteria:

  • Patients aged under 18 and over 85
  • Patients having no breast cancer HER2+
  • Patients with metastases
  • Heart failure (LVEF ≤50%) and respiratory (O2 saturation ≤ 92%),
  • Autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis)
  • Symptomatic osteoarthritis,
  • Cardiovascular diseases (angina or uncontrolled high blood pressure) or heart-lung (chronic obstructive pulmonary disease)
  • Patients suffering from malnutrition (Body Mass Index (BMI) <18 kg m-2) or weight loss of over 10% during the last 3 months,
  • Patients with psychiatric or cognitive disorders deemed unsuitable for a sporting activity
  • Pregnant or lactating Patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Physical activity intervention
- Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months
Other: Physical activity intervention
Patients in arm A (interventional) will carry out a physical activity intervention during 3 months. Patients should perform an interval training program on cycle-ergometer during 3 sessions per week.
Active Comparator: Control group
- Arm B (control group) "standard oncologic care"
Other: Control Group
standard oncologic care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Left Ventricular Ejection Fraction (LVEF)
Time Frame: The Left Ventricular Ejection Fraction (LVEF) will be evaluated baseline (T0), and 6 months (T6), to see if there is a significant change
evaluated with echocardiography
The Left Ventricular Ejection Fraction (LVEF) will be evaluated baseline (T0), and 6 months (T6), to see if there is a significant change

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight and volume of left and right ventricular
Time Frame: baseline (T0), 3 months (T3) and 6 months (T6)
evaluated with echocardiography
baseline (T0), 3 months (T3) and 6 months (T6)
Body composition
Time Frame: baseline (T0), 3 months (T3) and 6 months (T6)
evaluated byimpedance and with tape measure and pliers of Harpenden
baseline (T0), 3 months (T3) and 6 months (T6)
Metabolic responses
Time Frame: baseline (T0), 3 months (T3) and 6 months (T6)
evaluated with enzyme-linked immunosorbent assay (ELISA)
baseline (T0), 3 months (T3) and 6 months (T6)
Maximal voluntary quadriceps
Time Frame: baseline (T0), 3 months (T3) and 6 months (T6)
evaluated with chair quadriceps with strain gauge
baseline (T0), 3 months (T3) and 6 months (T6)
score of Quality of life
Time Frame: Baseline (T0), 3 months (T3) and 6 months (T6)
evaluated with questionnaire
Baseline (T0), 3 months (T3) and 6 months (T6)
score of Pain
Time Frame: Baseline (T0), 3 months (T3) and 6 months (T6)
evaluated with questionnaire
Baseline (T0), 3 months (T3) and 6 months (T6)
Fatigue
Time Frame: baseline (T0), 3 months (T3) and 6 months (T6)
evaluated with questionnaire
baseline (T0), 3 months (T3) and 6 months (T6)
Level of physical activity
Time Frame: baseline (T0), 3 months (T3) and 6 months (T6)
evaluated with questionnaire
baseline (T0), 3 months (T3) and 6 months (T6)
Pulmonary function (at rest and during exercise)
Time Frame: baseline (T0), 3 months (T3) and 6 months (T6)
evaluated with respiratory functional test and maximal exercise test
baseline (T0), 3 months (T3) and 6 months (T6)
hormonal responses
Time Frame: baseline (T0), 3 months (T3) and 6 months (T6)
evaluated with enzyme-linked immunosorbent assay (ELISA)
baseline (T0), 3 months (T3) and 6 months (T6)
inflammatory responses
Time Frame: baseline (T0), 3 months (T3) and 6 months (T6)
evaluated with enzyme-linked immunosorbent assay (ELISA)
baseline (T0), 3 months (T3) and 6 months (T6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Franche-Comté

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre Hospitalier Universitaire de Besancon
Ligue contre le cancer, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathalie Meneveau, University Hospital of Besancon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UFranche-Comte

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